Pesticides and Biocides Notification

Overview:

The importance of pesticides and biocides to the food and agricultural and public health sectors, respectively, of the global economy cannot be understated. For all their benefits, however, pesticides and biocides have had a checkered past. Because of the attendant potential risks of these otherwise invaluable products, authorities worldwide have in place regulatory schemes for the registration and monitoring of pesticides and biocides.  

The U.S. requires compliance under its Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) for producers of pesticides and biocides. European Union (EU) Member States require compliance with several EU legislative instruments concerning the placing of plant protection products (PPP) on the EU market (EC Regulation 1107/2009), the placing of biocidal products on the market (EC Regulation 528/2012), and the sustainable use of pesticide products (Directive 2009/128/EC). This raft of legislation is difficult to navigate and the approval process can be protracted and unpredictable. Authorizations for biocidal active substances and/or biocidal products can be sought either at the EU level, granting permission to supply products freely across the EU area, or at the Member State level, allowing products to be placed on the market in individual EU countries. Under the latter option, additional Member State authorizations can be obtained as needed, often at reduced costs, information burdens, and processing times.

The costs for approval, registration, and maintenance in a market can be daunting. But with strategic planning and coordination, companies can recapture those costs and meet long-term success. The Acta Group’s (Acta^®) professionals have the scientific, regulatory, and strategic know-how to help clients in the pesticide and biocides spaces reach their markets and stay there.

Our Experience:

Acta professionals have substantial experience in the developing law, regulation, and policy of products implicated under FIFRA, the various EU directives, and other similar regulatory schemes across North America, South America, Europe, and Asia.

James V. Aidala has over 30 years of experience in the field of pesticide legislation, policy, and implementation. Before joining Acta, Mr. Aidala was Assistant Administrator of the U.S. Environmental Protection Agency’s (EPA) Office of Prevention, Pesticides, and Toxic Substances (OPPTS) (now the Office of Chemical Safety and Pollution Prevention (OCSPP)). Both at EPA and during earlier work for Congress’s Subcommittee on Environment, Energy, and Natural Resources, Mr. Aidala was deeply involved in FIFRA matters, in charge of oversight of EPA’s implementation of FIFRA while working on Capitol Hill.

Lynn L. Bergeson has assisted clients for many years in resolving and advocating on often precedent-setting, novel, and complex pesticide regulatory issues. Ms. Bergeson is engaged in the evolving law and policy of nano pesticides, biocides, and inerts and the emerging regulatory programs developing to register these products.

Sheryl Lindros Dolan works with registrants of agricultural and other conventional pesticides, antimicrobial products, biopesticides, and plant regulators to register and manage compliance with requirements under FIFRA.

Lara A. Hall, M.S., a scientist and Registered Quality Assurance Professional in Good Laboratory Practice (RQAP GLP), assists clients in ensuring scientific integrity and regulatory compliance through all phases of data development in support of new and existing product registrations worldwide and interfacing with a global network of regulatory bodies including EPA (FIFRA) and the European Chemicals Agency (ECHA) (Biocidal Products Regulation (BPR).

Jane S. Vergnes, Ph.D., has 25 years of toxicology and product stewardship experience with major international chemical companies that manufacture FIFRA-regulated products that are a tremendous asset to those clients needing data review and interpretation, study monitoring, hazard characterization, or assistance in preparing data for submission to regulatory authorities across the globe.

Heather F. Collins, M.S., works with pesticide producers to ensure FIFRA compliance, including determining data requirements, label requirements, and registration requirements. Ms. Collins has specific expertise in biocide and pesticide compliance strategies under FIFRA, and has established training programs and provided training to ensure applicable federal and state laws and regulations are followed.

What We Do:

Acta professionals routinely advise clients on a full range of pesticide and biocide regulatory matters, including registration, reregistration, compliance, and defense. Our work includes the following:

• Product Registration, Reregistration, and Registration Review –
  • Assist clients across registration, reregistration, and registration review issues, such as:
    • Pesticide Registration Improvement Extension Act (PRIA 3) matters
    • Reregistration Eligibility Decision (RED) and Registration Review decision documents
    • California and other state registration requirements
    • PPP authorizations in accordance with Regulation (EC) No. 1107/2009
    • Biocidal active substance and biocidal product authorizations in accordance with EU Regulation 528/2012.
• Compliance –
  • Counsel clients on compliance matters, including those affecting marketing materials and claims, product production requirements, recordkeeping and reporting requirements, and data submission requirements
  • Train client personnel, from management to sales and marketing personnel, on compliance
• Marketing –
  • Counsel clients on product promotion that is compliant with relevant regulations
  • Address legal issues affecting product marketing
  • Assist clients in obtaining approval of expanded claims for products
• Enforcement before Regulatory Authorities and EU Member States –
  • Defend products in enforcement matters involving, among other issues:  labeling, export/import, and experimental use permits
  • Defend products in proceedings involving, among other issues:  Notices of Intent to Suspend, cancellations, and special reviews
• Data Protection and Compensation

Representative Engagements:

Acta is among the elite in pesticide law and  regulatory firms representing global product manufacturers on virtually every aspect of FIFRA/Food Quality Protection Act (FQPA) law, policy, science, and regulation.

• Acta assists both large and small product manufacturers and trade associations in tackling the daunting array of scientific, legal, and policy challenges confronting the agricultural chemical community. Acta professionals are intimately familiar with the legislative underpinnings of FIFRA and FQPA, and continue to work on legislative matters arising under FIFRA, the Clean Water Act (CWA), the Endangered Species Act (ESA), the Pesticide Registration Improvement Act (PRIA), and other laws applicable to agricultural practices.
• Acta routinely assists data owners in protecting and optimizing their financial investment in registration data relied upon by follow-on registrants and in negotiating data compensation settlements or assisting in data compensation arbitrations when settlement is not an option.
• Acta professionals have procured countless successes for clients in obtaining novel registrations, continuing challenged registrations, and/or diminishing the regulatory constraints on existing registered products.